About the Job
We are looking to strengthen our team in Denmark with a Senior Consultant / Serialization Specialist, who can help our clients navigate the increasingly complex landscape of pharmaceutical serialization and compliance.
Are you passionate about compliance, Computer Systems Validation (CSV), and serialization in the Life Sciences industry? Do you enjoy working at the intersection of IT, quality, and regulatory requirements—while advising clients on critical, business-impacting solutions? Then you could be our new colleague.
Your Role
As a Senior Consultant / Serialization Specialist, you will work closely with our clients to ensure compliant and efficient implementation and operation of serialization solutions across their IT landscape.
Depending on your experience, your responsibilities may include:
- Acting as SME within Serialization, supporting implementation, rollout, and optimization of serialization solutions
- Leading and supporting Computer Systems Validation (CSV) activities for serialization and related systems
- Defining and implementing compliance strategies aligned with global regulatory requirements
- Supporting IT/QA readiness assessments and developing validation approaches
- Advising clients on serialization regulations (e.g., EU FMD, US DSCSA) and industry best practices
- Driving vendor selection, evaluation, and oversight for serialization platforms
- Supporting integration of serialization systems with ERP, MES, and other enterprise systems
- Acting as a trusted advisor on compliance, quality, and governance within serialization programs
- Facilitating workshops with business, IT, and quality stakeholders
- Supporting audits and inspections related to serialization and validated systems
About Epista
Epista Life Science (Epista) is a trusted consulting company specializing in business process and IT services for the Life Sciences industry. Since our establishment in 2009 Epista has grown remarkably, expanding our services across Denmark, Sweden, Switzerland, Germany and US. Throughout our journey, we have consistently maintained outstanding employee and customer satisfaction. In 2022, we partnered with FSN Capital Partners, reinforcing our commitment to developing a global services platform dedicated to Life Science companies. With FSN onboard, we are looking forward to exciting market expansions as well as merge & acquisition activities.
Your Qualifications
We imagine that you bring:
- 5+ years of experience within IT compliance, serialization, CSV, or similar roles in the Life Sciences industry
- Hands-on experience with serialization systems (e.g., Level 3/4 solutions, reporting systems, integration layers)
- Strong knowledge of Computer Systems Validation (CSV) and/or Computer Software Assurance (CSA)
- Solid understanding of relevant regulations such as:
- EU GMP Annex 11
- FDA 21 CFR Part 11
- GAMP5
- Serialization regulations (EU FMD, US DSCSA)
- Experience working with regulated IT systems and compliance frameworks
- A strong consultancy mindset with excellent communication and stakeholder management skills
- Ability to translate complex regulatory requirements into practical, business-oriented solutions
- Experience working across IT, Quality, and Business domains
- Ability to manage multiple tasks and projects while maintaining high quality
- A proactive, collaborative, and solution-oriented approach
- A commercial mindset with motivation for recognizing client opportunities and bringing them to our sales team
On a typical day you might ...
As an Epista Senior Serialization Specialist, you’ll be working at the intersection of compliance and business as a part of our highly skilled and dedicated team. You’ll be involved in a wide variety of projects, primarily focusing on supporting clients with their serialization solutions – supporting ongoing operations and expansions into new markets or adopting/updating processes. Much of your time will be spent with our clients - international pharma and medical technology companies.
Your daily activities might include:
- Take a leading role in serialization and compliance projects, ensuring alignment with regulatory expectations
- Collaborate with client stakeholders across IT, Quality, Supply Chain, and Business functions
- Define and execute validation strategies and documentation for serialization systems
- Support system implementations and integrations, ensuring compliant design and operation
- Conduct vendor assessments and review supplier documentation
- Provide strategic advice on compliance, governance, and system lifecycle management
- Act as a bridge between IT, Quality, and Business, ensuring clear communication and alignment
- Prepare and facilitate workshops and stakeholder sessions
- Support audit readiness and inspection activities
- Contribute to development of internal best practices within serialization and CSV
- Share knowledge and continuously improve ways of working across the team
Why work at Epista?
Epista is a team of pioneers. We unlock each consultant’s potential to continuously improve. We pioneer new ways to stay in control of patient safety and product quality and question the status quo in everything we do.
Our unique team spirit makes a positive impact – on our clients and the Life Science industry. Here, you’re never alone. We all work together for everyone’s success. And each individual is strengthened by the knowledge of the group.
We’re proud to be Epista, for good reason. If you’re the cream of the crop, are you ready to join us?
